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Self-managed vs Supervised Exercise for Knee OA (SELFIT)

M

Marius Henriksen

Status

Not yet enrolling

Conditions

Knee Osteoarthritis

Treatments

Behavioral: Self-managed exercise in a fitness center
Behavioral: Supervised Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT07210931
APPI-MSK-OA-SELFIT

Details and patient eligibility

About

Knee osteoarthritis (OA) is a common painful condition associated with pain and disability. OA healthcare costs the Danish society 4.6 billion DKK more per year than the non-OA population and we lack evidence on how best to organize and deliver care to reduce costs. Recommended first line treatment for knee OA is exercise with proven effects on symptoms. The current paradigm assumes that exercise needs to be delivered and supervised by a physiotherapist which require patients to attend a clinic at specific times and geographical locations. This is an expensive model of care and creates barriers for people that are active on the labor market or lives in remote areas with long distances to the nearest clinic. In fact, the productivity loss in Denmark associated with OA is estimated to be 12.4 billion DKK per year.

While effective on symptoms, the current model with supervised physiotherapy associates with significant shortcomings, and barriers related to patient heterogeneity, costs, accessibility, and work absenteeism.

As an alternative, a local fitness center is far more accessible as these are widely dispersed across the country, are accessible daily (including weekends) at all hours, is cheap and offers a wide variety of exercise types, classes, and equipment to accommodate individual preferences. The cost of a fitness center membership is approximately 300 DKK per month and includes exercise ad libitum. In contrast, a typical physiotherapist-supervised exercise program costs 3-4,000 DKK for a 2-month treatment with 2 weekly sessions.

Consequently, there is a need to investigate if self-managed exercise in a fitness center is cost-effective as first-line management of knee OA. To answer this question, the present trial aims to compare self-managed exercise in a fitness center to the current standard - supervised exercise. This has the potential to improve quality of care for people with knee OA by adding a cost-effective option for first line management of people with knee OA.

Enrollment

300 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Diagnosis of knee OA according to the NICE criteria: Adults aged 45 or over with activity-related joint pain and either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes.

Exclusion criteria

  • Completion of a supervised therapeutic exercise program for knee OA within 3 months
  • Contraindication to exercise (e.g., resting systolic blood pressure > 200 or diastolic blood pressure >110 mmHg, acute or reoccurring chest pain, unstable angina. uncontrolled cardiac arrhythmias, decompensated heart failure. suspected or known dissecting aortic aneurysm)
  • Lack of independent mobility that requires aid for transportation to/from exercise facilities.
  • Any condition or impairment that, in the opinion of the recruiting GP, makes a potential participant unsuitable for participation or which may obstruct participation (e.g. psychiatric or cognitive disorders, language barriers, or opiate dependency).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

Self-managed exercise
Experimental group
Treatment:
Behavioral: Self-managed exercise in a fitness center
Physiotherapist-supervised exercise
Active Comparator group
Treatment:
Behavioral: Supervised Exercise

Trial contacts and locations

0

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Central trial contact

Camilla P Paulsen, Phd student; Marius Henriksen, Professor

Data sourced from clinicaltrials.gov

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